Welcome
to the first installment of Vaccines for the Future, featuring updates
from PATH’s vaccine development program. In the year and a half since PATH
launched this effort, we have established a solid foundation for the
development of new, appropriate vaccines for children in the developing
world. Our goal is to accelerate the development of life-saving vaccines for
pneumococcal and diarrheal disease, which kill over a million children each
year in the developing world.

We look forward to bringing
you information about our projects and progress in the vaccine development program
at PATH.

This month, PATH is
launching a new project to protect infants and children in low-resource
countries by advancing development of safe, affordable, and effective new
vaccines targeted against two of the most important bacteria that cause
diarrheal disease. We will collaborate with a number of private- and
public-sector partners to advance the development of promising vaccines against
the leading bacterial causes of diarrheal disease: Shigella and
enterotoxigenic Escherichia coli (ETEC). During the month of October,
we will issue a Request for Proposals for vaccine discovery and development
projects and research activities in support of vaccine development.

We are pleased to welcome
Dr. Richard Walker as the director of this project, the Enteric Vaccine
Initiative. Dr. Walker has over 25 years experience in vaccine development at
the Naval Medical Research Institute—where he directed the enteric diseases
program, the Armed Forces Radiobiology Research Institute, and Antex
Biologics, Inc. For the past seven years, he has served as Director, Division
of Bacterial, Parasitic, and Allergenic Products at the US Food and Drug
Administration.

PATH is working to advance
development of two new rotavirus
vaccines. In collaboration with the US National Institutes of Health and
Dr. Al Kapikian, PATH is providing a “shared
technology platform” to seven manufacturers developing a human bovine reassortant vaccine. Manufacturers
can access a host of technologies, training, and common
technical support that will help to maximize the production capacity and
global availability of rotavirus vaccine. In addition, we are directly
partnering with two manufacturers—Shantha
Biotech in India and the Wuhan
Institute of Biological Products in China—to provide financial support
and developmental assistance to accelerate development and clinical trials of
the human bovine reassortant vaccine.

For the past five years,
PATH has been part of a collaborative effort with Bharat Biotech
International (BBIL), the government of India, and leading experts in the
rotavirus field to develop the 116E vaccine. PATH is working
with BBIL and an expert consultative group on the Phase 1/2 clinical
trials of the 116E vaccine now underway.

In addition to these
efforts to develop new vaccines, the PATH Rotavirus Vaccine Program
is working with the GAVI Alliance, the World Health Organization, and the US
Centers for Disease Control to help countries access and afford the currently
licensed vaccines.

Expanding
protection against pneumonia

PATH is pursuing a number
of approaches to develop pneumococcal vaccines that will be effective and
affordable in the countries that most urgently need them. We partner with
scientists and manufacturers from initial discovery through clinical trials
to shorten the development timeline. Currently, PATH
is working with Intercell
AG, an Austrian biotechnology firm, on preclinical development of their common
protein vaccine, and Children’s
Hospital Boston on an inactivated whole cell vaccine approach. We recently
issued a Request for Proposals to support development of additional vaccine
candidates and other research efforts to advance the pneumococcal field, and
we anticipate beginning additional partnerships by the end of this year.

In response to widespread
concern that the highly pathogenic avian influenza
strain could evolve into one readily transmitted among humans, PATH is
conducting an analysis of influenza vaccine supply and demand as well as a
technical evaluation of influenza vaccine technologies. The analysis,
conducted in conjunction with Oliver
Wyman, Inc., highlights vaccine supply gaps and identifies promising new
approaches for development of new influenza vaccines. Because most currently
available influenza vaccines are egg-based, if the avian flu becomes a
pandemic strain, decimated poultry flocks could make vaccine supplies even
more constrained—underscoring the need for innovative vaccine technologies.

PATH’s vaccine development
program is working to accelerate development of innovative, safe, effective,
and affordable vaccines for the diseases that are the leading causes of
childhood deaths in the developing world: pneumococcal disease, diarrheal
disease, and influenza. PATH is also partnering on vaccine development
through its Malaria Vaccine Initiative and the Meningitis Vaccine Program. The
work of the vaccine development program is currently supported by grants from
the Bill & Melinda Gates Foundation.